Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)
NCT ID: NCT01117220
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2010-06-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2
Placebo
Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID) to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).
1
Ziprasidone Oral Capsules
Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).
Interventions
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Placebo
Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID) to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).
Ziprasidone Oral Capsules
Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.
* The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive
Exclusion Criteria
* Any history of serious or unstable illness
* Risk for prolonged QT
10 Years
17 Years
ALL
Yes
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1281196
Identifier Type: -
Identifier Source: org_study_id
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